| CTRI Number |
CTRI/2024/05/067639 [Registered on: 20/05/2024] Trial Registered Prospectively |
| Last Modified On: |
17/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A comparative study between ropivacaine versus levobupivacaine for spinal anaesthesia |
|
Scientific Title of Study
|
A Comparative Evaluation of Hyperbaric Ropivacaine with
Fentanyl and Hyperbaric Levobupivicaine with Fentanyl for Inguinal Hernia Surgeries under Spinal Anaesthesia |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sujani Gooty |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College |
| Address |
Department of Anaesthesia
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
9493626838 |
| Fax |
|
| Email |
hemanthasujanireddy@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujani Gooty |
| Designation |
Assistant Professor |
| Affiliation |
Government medical college |
| Address |
Department of Anaesthesia
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
9493626838 |
| Fax |
|
| Email |
hemanthasujanireddy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujani Gooty |
| Designation |
Assistant Professor |
| Affiliation |
Government Medical College |
| Address |
Department of Anaesthesia
Cuddapah
ANDHRA PRADESH
516002
India |
| Phone |
9493626838 |
| Fax |
|
| Email |
hemanthasujanireddy@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia
Government Medical college
Kadapa
Andhra Pradesh
India
Pin code 516004 |
|
|
Primary Sponsor
|
| Name |
Dr Sunil chiruvella |
| Address |
Department of Anesthesiology
Government medical college
Kadapa
Andhra Pradesh
India
Pincode 516004 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sujani Gooty |
Government General hospital |
Department of Anesthesiology
Operation Theatre
Room no 200
Inpatient block
Cuddapah
ANDHRA PRADESH |
9493626838
hemanthasujanireddy@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Government Medical College Kadapa |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
0.5% hyperbaric levobupivacaine |
2.5ml of 0.5% levo bupivacaine with 0.5 ml (25mcq) fentanyl |
| Intervention |
0.75% hyperbaric ropivacaine |
2.5ml of 0.75% hyperbaric ropivacaine with 0.5ml(25mcq) fentanyl |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
ASA 1 and 2
Age between 18 to 65 years Patients undergoing unilateral inguinal hernia
|
|
| ExclusionCriteria |
| Details |
Coagulation disorders
Local site infection
Neurological disorders
Psychiatric disorders
Patient refusal
Hypersensitivity to drugs used in the study |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare onset and duration of sensory and motor blockade |
2 min
3 min
6 min
10 min
15 min
30 min
45 min
60 min
2 hr
3 hr
6 hr |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor hemodynamic parameters and observe adverse effects |
2 m8n
3 min
6 min
10 min
15 min
30 min
45 min
60 min
2 hr
3 hr
6 hr |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
28/05/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Levobupivacaine, an amide local anesthetic is an S-enantiomers of bupivacaine. It has equivalent clinical effi cacy to bupivacaine and less cardiotoxic. Ropivacaine is similar in chemical structure to bupivacaine, but it is 30-40% less potent. It has shorter duration of action than bupivacine. Intrathecal opioids synergistic with local anaesthetics and intensify the sensor block and hastening recovery times.The aim of the study is to compare the onset, duration of sensory block and motor block, postoperative analgesia and haemodynamic changes occurring with 0.75% hyperbaric ropivacaine with fentanyl and 0.5% hyperbaric levobupivacaine with fentanyl when given intrathecally.A Prospective randomized double blind study will be conducted in 60 patients undergoing inguinal hernia surgeries will be divided in two groups. Group LF (n = 30): 2.5 ml of 0.5% levobupivacaine (hyperbaric) + 0.5 ml fentanyl(25µg) group RF (n = 30): 2.5 ml of 0.75% ropivacaine (hyperbaric) + 0.5 ml fentanyl(25µg). |